Biologic agents for add-on therapy for treatment of adults with CRSwNP

Agent and target	CRSwNP study primary outcomes	Indications in addition to CRSwNP	CRSwNP dose and route	Administration options	Most common adverse effects in CRSwNP	Other important adverse events reported with drug
Dupilumab, anti-IL-4R alpha	NPS: SINUS 24: 2.06 point reduction (95% CI –2.43 to –1.69) SINUS 52: 1.80 point reduction (95% CI –2.10 to –1.51) NCS: SINUS 24: 0.89 point reduction (95% CI –1.07 to –0.71) SINUS 52: 0.87 point reduction (95% CI –1.03 to –0.71)^[1]	Atopic dermatitis Moderate-to-severe eosinophilic asthma Eosinophilic esophagitis Prurigo nodularis	300 mg SUBQ every 14 days	Self-administration	Injection-site reactions Eosinophilia Insomnia Toothache Gastritis Arthralgia Conjunctivitis^[2]	Keratitis Oral and other herpes simplex viral infections
Omalizumab, anti-IgE	NPS: POLYP 1: 1.14 point reduction (95% CI –1.59 to –0.69) POLYP 2: 0.59 point reduction (95% CI –1.05 to –0.12) NCS: POLYP 1: 0.55 point reduction (95% CI –0.84 to –0.25) POLYP 2: 0.50 point reduction (95% CI –0.80 to –0.19)^[3]	Allergic asthma Chronic spontaneous urticaria	75 mg to 600 mg SUBQ every 2 or 4 weeks based on weight and serum IgE level	Office administration or self-administration after 3 observed doses in the office in patients without history of anaphylaxis	Headache Injection-site reactions Arthralgia Upper abdominal pain Dizziness^[4]	Anaphylaxis, immediate or delayed Thromboembolic disease
Mepolizumab, anti-IL-5	NPS: 0.73 point reduction (95% CI –1.11 to –0.34) Nasal obstruction VAS: 3.14 point reduction (95% CI –4.09 to –2.18)^[5]	Severe asthma with eosinophilic phenotype Hypereosinophilic syndrome Eosinophilic granulomatosis with polyangiitis	100 mg SUBQ every 28 days	Office administration or self-administration	Oropharyngeal pain Arthralgia^[6]	Headache Anaphylaxis Herpes zoster infections; administration of zoster vaccine is suggested prior to start

Endoscopic NPS measurement – Scale of 0 (no polyps) to 8 (complete obstruction of nasal cavity bilaterally).
NCS – Scale of 0 (no congestion) to 3 (severe congestion).
Nasal obstruction VAS – Scale of 0 (no obstruction) to 10 (severe obstruction).

CRSwNP: chronic rhinosinusitis with nasal polyposis; IL-4R: interleukin 4 receptor; NPS: nasal polyp score; SINUS 24 and 52: Controlled Clinical Studies of Dupilumab in Patients with Bilateral Nasal Polyp; NCS: nasal congestion score; SUBQ: subcutaneous; IgE: immunoglobulin E; POLYP 1 and 2: Participants with Chronic Rhinosinusitis with Nasal Polyps trials 1 and 2; IL-5: interleukin 5; VAS: visual analog scale.

References:

Bachert C, Han JK, Desrosiers M, et al. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): Results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials. Lancet 2019; 394:1638.
Dupilumab injection. United States prescribing information. Revised October, 2022. US National Library of Medicine. (Available online at www.dailymed.nlm.nih.gov/dailymed/index.cfm, accessed January 23, 2023.)
Gevaert P, Omachi TA, Corren J, et al. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials. J Allergy Clin Immunol 2020; 146:595.
Omalizumab injection. United States prescribing information. Revised July 2021. US National Library of Medicine. (Available online at www.dailymed.nlm.nih.gov/dailymed/index.cfm, accessed January 23, 2023.)
Han JK, Bachert C, Fokkens W, et al. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med 2021; 9:1141.
Mepolizumab injection. United States prescribing information. Revised January, 2022. US National Library of Medicine. (Available online at www.dailymed.nlm.nih.gov/dailymed/index.cfm, accessed January 23, 2023.)

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Biologic agents for add-on therapy for treatment of adults with CRSwNP